The Short Version
FDA: Validate your tests please.
23andMe: Look, we have fancy marketing videos!
FDA: Ok, validate your tests very soon please.
23andMe: Look, we can tell you about these two hundred other conditions that might cause you cancer!
FDA: Uh, we’ve been asking you for a while to validate those tests of yours…
23andMe: Did you know our CEO is the ex-wife of a Google founder?
FDA: That’s nice, but can you please validate the tests you are selling to the public? We have laws here that require you to do this in order to market it as a medical test and we’re interested in protecting the safety of the people.
23andMe: Look, we’re doing a media blitz on Facebook and with TV ads selling this as an essential medical test! Just in time for the holidays! Anyone interested in a DNA spit party? 23andMe kits for everyone!
FDA: Ok, that’s it! You’ve been dumping money into marketing for years and refusing to answer the legal mandate that you validate the damn test. Fellas [motions to hench-people waiting nearby] shut ‘em down!
The Two Sins: Arrogance and Not Doing Your Homework
Generally speaking, anything that you come into contact with that you could eat, put into your system, or smear on you (I’m looking at you, young professional woman on the 6 train I see putting on makeup artfully before getting off at 51st St), we expect to be tested and proven to be ok for us to use or eat. Making sure products are tested and approved is regulated by the Food and Drug Administration as they implement a variety of laws.
The quirk of the genome age is that some really bright researchers have developed cheaper and generally more precise ways to figure out all the little letters in your genome. In some very select cases, we even have some level of understanding of increased or decreased risk of certain kinds of diseases. Bottom line, we know a few things. Not a lot, but a little. This is a good thing, even a great thing. But, we’re now inundated with data and struggling to understand what it all means and then test out those hypotheses to see if what we think is happening is true or an utter failure (and in science, most of the time, what we think is going on turns out to be an utter failure… that’s why it’s called RE-search).
A few years ago 23andMe came along with the cool kid attitude and big bold claims of all the things they can tell you about your genome. The problem is they started telling consumers that they knew a lot and could provide you with accurate and useful information about your genome. Everyone has a friend who might be prone to claiming they know more than they do. We generally have a little less trust in that friend when it comes to accuracy. In science, and genomics in particular, the difference between what we know and what we don’t is enormous. At this point, we’re still figuring out how much we don’t know. We’re not at the stage where we are filling in the gaps. So sin number one for 23andMe is overselling what you know and coming across as an arrogant know-it-all.
The second sin is the deadly one the FDA shut down 23andMe over. The test the company provides results for isn’t proven yet and 23andMe claims in public through a dizzying array of advertisements that it is reliable. The FDA asked time and again over at least a four year period for additional studies validating the genetic testing results that 23andMe was providing to consumers. Instead of doing the research, they turn around and dump more money into advertising. What do you call a kid that doesn’t do his homework? In most cases, you call that kid a C student at best. You certainly don’t want to take medical advice from that kid, and you shouldn’t take it from 23andMe either.
Today, the FDA finally took a stand against a self-promoting student who never did their homework – 23andMe. It only took them four years to do it, but I’m glad they did.
What Could Happen Next
Some of this is a very long argument over what is a medical test and what isn’t. Also, some of this is a rather esoteric (but incredibly important) argument over what the statistical data tells us about the predictability of actual outcomes that correlate to genetic information. That part is one of the holy grails in biology.
One path is that we let this go the route of in-home isolation of DNA from various fruits or other household organic items. The issue here is that the devil (or angels if you discover you have a series of genes that will give you a high likelihood of living until you are 100) is in the data. With little parlor trick science you don’t usually get the details. You get some kind of demonstration that you can’t do anything with. Direct-to-consumer genetic testing can give you the details. You can infer (right now through mathemagic) all kinds of things that someone predisposed toward self-diagnosing could work themselves up pretty bad over.
What nobody wants to see is a negative impact on the research and attempts to lower its cost, increase accuracy, and move us towards a higher resolution understanding of biology. Those things all serve individuals and society collectively really well. It can inform and improve preventative care, help with diagnosis and treatment of rare or complicated diseases, and at some point might contribute to decreases in health care costs.
This smackdown of 23andMe is an important wake up call. It’s a firm statement that adequate monitoring is necessary. The FDA is saying that it’s important that scientists confirm and validate results before people go off trying to sell it to the public.
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